Evaluation of an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care (CDSSR18)
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|ClinicalTrials.gov Identifier: NCT02925962|
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment|
|Hypertension Renal Insufficiency, Chronic||Other: Clinical Decision Support System (CDSS) Other: Clinic Decision Sup System + Pharmacist|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial to Evaluate an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care|
|Actual Study Start Date :||August 14, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: Clinical Decision Support System (CDSS)
PCPs get a notice the CKD Clinical Decision Support System (CDSS) is available.
Other: Clinical Decision Support System (CDSS)
A targeted, automated CKD clinical decision support system (CDSS) designed to improve bloodpressure (BP) level, disease awareness, staging, processes of care, and knowledge among persons with documented reduced eGFRcreat (creatinine-based estimated glomerular filtration rate) in primary care setting.
Experimental: Clinic Decision Sup System + Pharmacist
The Clinical Decision Support System + Pharmacist follow-up call extends beyond the CDSS alone.
CDSS Plus overview:
Other: Clinic Decision Sup System + Pharmacist
Includes everything in the CDSS intervention but adds a follow-up call from a pharmacist, who is part of the clinical team. The rationale for this third arm is based on the evidence that clinical pharmacists have been shown to be more effective than physicians alone at achieving BP control in other settings.
Other Name: CDSS Plus, Clinical Decision Support System + Pharmacist
No Intervention: Usual Care
Patients continue to receive usual care by their provider.
- Change in blood pressure from enrollment [ Time Frame: Investigators will follow patients up to 2 years after measures ]Clinical Outcome: The primary clinical outcome of the trial is change in blood pressure (mmHg) from enrollment to the end of the follow up period as a continuous outcome, ascertained from the electronic medical record. BP measures from the clinical record will be ascertained in no more than quarterly intervals in the primary care setting to avoid bias by ascertainment. Investigators will also consider the dichotomous clinical outcome "achieved sustained BP control", defined as BP < 140/90 mmHg in ≥ two consecutive visits during the trial.
- Feasibility [ Time Frame: Investigators will follow patients up to 2 years after measures ]Investigators will assess provider awareness of CKD, defined as percent appropriate inclusion of CKD in the problem list (dichotomous outcome).
- Processes of Care [ Time Frame: Investigators will follow patients up to 2 years after measures ]Investigators will also measure use of ACEI/ARB among persons with albuminuria, measured as the proportion (percent) of persons on these medications at the end of the study period, compared to enrollment. Medication prescription will be ascertained by percent with an electronic record of a new order or modification during the study period, not including refills. Other process outcomes relate to feasibility and the ability to implement the CDSS protocol. These include proportion in the intervention arms with completion of albuminuria and cystatin C testing.
- CKD and NSAID avoidance Knowledge [ Time Frame: Investigators will interview each participant 2 weeks after their primary care visit or clinical pharmacist phone call ]Patient-centered outcomes: Investigators will evaluate CKD and NSAID avoidance knowledge (proportion with correct answers), using structured telephone interviews, and comparing patients from the three study arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925962
|Contact: Carmen A Peralta, MD, MAS||415-476-2173||CarmenAlicia.Peralta@ucsf.edu|
|Contact: Erica Day, MPH||4152214810 ext firstname.lastname@example.org|
|United States, California|
|UCSF Division of General Internal Medicine||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Leah K Karliner, MD 415-353-7900 email@example.com|
|Contact: Sarita Pathak, MPH 415-502-1317 firstname.lastname@example.org|